Roflumilast Versus Methotrexate in Psoriasis

Psoriasis Clinical Trial

Official title:

Roflumilast Versus Methotrexate in the Treatment of Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684744
• Other study ID #: Kapu27
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 9, 2023
• Est. completion date: May 14, 2023

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis

Description:

Phosphodiesterase (PDE-4) activity was found to be greater in psoriatic skin than in healthy skin. Inhibition of PDE-4 inhibits the hydrolysis of cyclic AMP in inflammatory cells, which increases intracellular cAMP and results in down-regulation of immune modulators, including tumor necrosis factor (TNF)- α, interferon-γ, interleukin (IL)-17, and IL-23. Roflumilast is a potent and selective inhibitor of PDE-4 which is already approved in its oral form for chronic obstructive pulmonary disease. Regarding Roflumilast's topical form, it is currently also approved in the treatment of psoriasis. Lebwohl et al., 2020 found that roflumilast cream was efficacious in reducing the severity of psoriasis in a 12-week, randomized, double-blind, placebo vehicle-controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 14, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with psoriasis vulgaris

2. Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study

3. Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study

Exclusion Criteria:

1. Erythrodermic or pustular psoriasis

2. Pregnant and lactating females

3. Patients with autoimmune diseases e.g. systemic lupus erythematosus

4. Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Roflumilast
The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks
• Methotrexate
The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Severity Index (PASI) before and after Roflumilast	Comparison of Psoriasis Severity Index (PASI) before and after treatment with Roflumilast, where the lower score indicates clinical improvement. PASI score ranges from 0-72.	12 weeks
Primary	Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate	Comparison of change of Psoriasis Severity Index (PASI) after treatment with roflumilast and after treatment of methotrexate where the lower score indicates clinical improvement. PASI score ranges from 0-72.	12 weeks